Theolytics, a biotechnology company focused on oncolytic immunotherapies, has dosed the first patient in its Phase I/IIa clinical trial (OCTOPOD - NCT06618235) evaluating THEO-260 in patients with advanced-stage platinum-resistant ovarian cancer (PROC). This multi-center, open-label, first-in-human trial marks a significant step in addressing the unmet needs of women with this challenging disease.
Addressing Ovarian Cancer's Stromal-Rich Microenvironment
Ovarian cancer is a leading cause of cancer-related deaths in women, characterized by a stromal-rich, immune-suppressed tumor microenvironment (TME) abundant with cancer-associated fibroblasts (CAFs). These CAFs contribute to chemo-resistance, relapse, T-cell exclusion, and disease progression. THEO-260 is designed to combat these challenges by lysing both ovarian cancer cells and CAFs, while also triggering immunogenic cell death and promoting T-cell activation, based on preclinical studies.
THEO-260: A Mechanistically Novel Oncolytic Immunotherapy
THEO-260, identified using Theolytics’ discovery platform of over 100 million oncolytic candidates, is a mechanistically differentiated adenovirus specifically selected for high-grade serous ovarian cancer. Its ability to target both cancer cells and CAFs, coupled with its immunogenic properties, offers a multi-faceted approach to treating PROC, a complex solid cancer with limited treatment options.
Clinical Trial Details and Expert Commentary
The Phase I/IIa trial aims to evaluate the safety and tolerability of THEO-260 when administered intravenously, as well as to determine the recommended Phase 2 dose. The study will also include comprehensive biomarker analysis to demonstrate THEO-260’s oncolytic mechanism in the clinic.
Dr. John Krell, Clinical Reader & Consultant Medical Oncologist at Imperial College London and Chief Investigator, noted, "Whilst many patients respond very well to initial treatment, relapse from remission is common and further treatment is needed to try to control the disease... There remains a lack of good treatment options with few advances in the last decades and is a significant unmet need in this population. The extensive preclinical data with THEO-260 in ex vivo patient samples is very encouraging and gives promise of a differentiated approach for ovarian patient treatment."
Margaret Duffy PhD, Theolytics CSO and Co-Founder, added, "Enrolling the first patient into our Phase I/IIa trial for THEO-260 marks a major milestone for Theolytics... Using our discovery platform, THEO-260 has been developed to combat the stromal rich nature of this advanced solid cancer, and we look forward to reporting on the progress of this trial."
About THEO-260
THEO-260 is an adenoviral oncolytic immunotherapy designed to address the immune-suppressed nature of advanced solid tumors. Preclinical models, including ovarian cancer patient samples, have demonstrated its ability to effectively kill cancer cells and CAFs while inducing immune activation. A clinical study of THEO-260 administered by intraperitoneal delivery to advanced ovarian cancer patients is also being planned.
